The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Vega Medical Suction Equipment, Model Su-01/su-dc01.
Device ID | K102626 |
510k Number | K102626 |
Device Name: | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
Contact | Joseph Lu |
Correspondent | Joseph Lu VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-13 |
Decision Date | 2010-11-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10822383509140 | K102626 | 000 |
10822383509133 | K102626 | 000 |
00848530088965 | K102626 | 000 |
00845717004398 | K102626 | 000 |
10848530102576 | K102626 | 000 |